Effect of Dexmedetomidine and Total Intravenous Anesthesia on Endothelial Damage-Related Biomarkers

Firat University

Status and phase: Completed; Phase 4

Conditions: Heparan Sulpahate; Dexmedetomidine; Syndecan 1; Endothelial Damage

Treatments: Drug: Dexmedetomidine+propofol+remifentanyl group; Drug: propofol+remifentanyl group

Study type: Interventional

Funder types: Other

Identifiers

NCT06897696

ETHICAL APPROVAL 31335

Details and patient eligibility

About

This study aimed to evaluate whether dexmedetomidine has a protective effect on endothelial damage by measuring plasma syndecan1 and heparan sulphate levels in rhinoplasty patients who take propofol+remifentanyl infusion.

Full description

Endothelial Glycocalyx (EG) is a carbohydrate-rich network covering the apical surface of endothelial cells. It consists of sulphated glycoproteins linked to sialic acids (heparan sulphate, dermatan sulphate), core proteoglycans (mainly syndecan-1) and unsulphated glycosaminoglycans (CD 44) directly attached to the cytoplasmic membrane of endothelial cells. The fragile nature of endothelial glycocalyx makes it highly susceptible to damage, especially in critical diseases such as septic shock and inflammation, ischaemia-reperfusion (IR) syndrome, oxidative stress and major trauma. Endothelial glycocalyx damage worsens the patient's clinical outcome, leading to capillary leakage, tissue oedema, immune system disorders, and thrombosis.

Despite the widespread use of transmission electron microscopy, fluorescence microscopy and intravital microscopy in experimental investigations, these methods are not applicable at the bedside. The second most widely used method to investigate endothelial glycocalyx is biochemical analysis of EG degradation products (e.g. syndecan-1, heparan sulphate, hyaluronan).

In surgical procedures, general anaesthesia is a pharmacological method used to control pain and consciousness. The agents administered in this process may be associated with both hypnotic and analgesic mechanisms acting on the central nervous system and side effects on the autonomic nervous system and circulatory system. Pharmacological agents used during general anaesthesia may exert pro-inflammatory or anti-inflammatory effects on the endothelium directly or indirectly. Some anaesthesia modalities may trigger endothelial damage by increasing oxidative stress, free radical production and the release of inflammatory cytokines. On the other hand, some techniques may show endothelial protective properties; this is related to the dose, duration and pharmacodynamic properties of the agents used. Because there is no pharmacological agent to prevent EG damage, it is important to prevent EG degradation in patients undergoing surgery. For all these reasons, evaluating the effects of general anaesthesia on endothelial function may provide important information for the protection of vascular health during and after surgery.

This study aimed to evaluate whether dexmedetomidine has a protective effect on endothelial damage in rhinoplasty patients under general anaesthesia by measuring plasma syndecan1 and heparan sulphate levels.

Enrollment: 90 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:patients between the ages of 18-50 who will undergo rhinoplasty will be included in the study -

Exclusion Criteria:patients who do not agree to participate in the study, patients with underlying peripheral arterial disease, coronary artery disease, hypertension, diabetes mellitus, and ASA (American Society of Anaesthesiologists) Classification ≥3 will be excluded.

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Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

propofol+remifentanil

Active Comparator group

Description:

to maintain anesthesia and analgesia propofol 5-8 mg/kg/h and remifentanil 5-10 µg/kg/h will be administered to all patients

Treatment:

Drug: propofol+remifentanyl group

dexmedetomidine+propofol+remifentanyl group

Active Comparator group

Description:

The dexmedetomidine+TIVA group will receive a bolus of 0.8-1 µg/kg dexmedetomidine for 10 minutes followed by continuous dexmedetomidine infusion at a rate of 0.3-0.5 µg/kg/hour.

Treatment:

Drug: Dexmedetomidine+propofol+remifentanyl group